BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Bio-Medicus®

    DI: 00613994530639 · Model: 98800-128 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bio-Medicus®
    Primary DI
    00613994530639
    Version / Model
    98800-128
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-04
    Public Version
    4
    Public Version Date
    2022-08-05
    Public Version Status
    Update
    Public Device Record Key
    ccf41ef2-49d7-4a71-9b17-0e3369dfce2a
    Distribution End Date
    2017-07-12

    Device Description

    CANNULA 98800-128 BIO-MED ART 12F LL CON

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    34905 Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

    Identifiers

    Type ID
    Primary 00613994530639

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K924642 000

    Device Sizes

    Type Value Unit Text
    Catheter Gauge 12.0 French
    Length 11.0 Centimeter